510(k) · Cleared
ClearedOrthocem, Ortho Bite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentscare Ltda · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Aug 14, 2020 as substantially equivalent to K880393 (Unitek Corp., 1988) and 1 other predicate after a 323-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Aug 14, 2020
- Review
- 323 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880393 (1988). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K210349TKO Composite Bite Turbo GelReliance Orthodontic Products, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880393 | Transbond Light Cured Orthodontic Adhesive | Unitek Corp. | 1988 | — |
| 0 (this device) | K192682 | Orthocem, Ortho Bite | Dentscare Ltda | 2020 | — |
| +1 | K210349 | TKO Composite Bite Turbo Gel | Reliance Orthodontic Products, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DYH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DYH device
- #1 K261840 BracePaste Prime Plusscore 13.8 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K880393 | Transbond Light Cured Orthodontic AdhesiveSummary page 5…ce: The Orthocem and Ortho Bite are equivalent with the following products: 510(k) Number Model Company K880393 Transbond™ XT 3M Unitek (primary predicate) I) Secondary Pre… | 1988 |
| * | K924151 | Bisco D/C ResinomerSummary page 5…BISCO, INC. (Reliance Bisco D/C Resinomer (Ultra Orthodontic Products, Inc. as K924151 Band-Lok) Repackager/Relabeler;… | 1992 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210349 | TKO Composite Bite Turbo Gel | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DYH devicesDYH Adhesive, Bracket And Tooth Conditioner, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DYH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYH
143in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYH
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DYH
1in 2025
MAUDE reports naming product code DYH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 62 | 1 | 2 |
| 2008 | 6 | 72 | 0 | 1 |
| 2009 | 3 | 77 | 0 | 1 |
| 2010 | 4 | 96 | 0 | 5 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 3 | 82 | 0 | 3 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 5 | 135 | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 3 | 143 | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 3 | 87 | 0 | — |
What is it indicated for?
Orthocem
Cementation of metal, ceramic or polycarbonate brackets or tubes to enamel surface.
Ortho bite
The product is indicated for cementing orthodontic bands and is also suitable for
temporary dental disocclusion during orthodontic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192682: Orthocem, Ortho Bite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192682
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026